Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Sever… (NCT07081776) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Effects on Carbon Dioxide (paCO2) of a New Oronasal Mask in Patients With Severe COPD Exacerbation Requiring Non-Invasive Mechanical Ventilation
Italy21 participantsStarted 2025-08
Plain-language summary
This single-center, crossover study aims to investigate the effects of the new OptiNIV oronasal mask used during NIV in COPD patients with respiratory acidosis following an exacerbation. The goal is to evaluate whether the clinical benefits, in terms of reducing PaCO2 levels, are greater with the new mask compared to a traditional one (Visairo Mask).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Informed consent obtained
* Patients with COPD and acute hypoxemic-hypercapnic respiratory failure (pH \< 7.35, PaO₂ \< 60 mmHg, PaCO₂ \> 45 mmHg) requiring non-invasive mechanical ventilation.
Exclusion Criteria:
* BMI ≥ 30 kg/m²
* Obstructive sleep apnea syndrome
* Neuromuscular diseases or chest wall pathologies
* Need for intubation and invasive mechanical ventilation during exacerbation
* Use of home non-invasive mechanical ventilation or CPAP
* Contraindications for NIV
* Cognitive disorders that may interfere with adherence to treatments
* Patients with active and unstable coronary artery disease
* Previous esophageal surgery, known esophageal stenosis, or any other condition that could put the patient at risk during the placement of the respiratory mechanics probe
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the effects of the OptiNIV oronasal mask on partial pressure of carbon dioxide (PaCO₂) levels in patients with severe COPD exacerbation requiring treatment with non-invasive mechanical ventilation.